Comparative Study Between Level I and Level II Temporomandibular Joint Arthroscopy in Wilkes Stage III Patients

October 25, 2024 updated by: Mohamed Gamal Thabet

Temporomandibular Joint Dysfunction (TMJD)

Temporomandibular joint dysfunction (TMJD) represents a common health problem. Its prevalence is nearly 31% in adults and 11% in adolescence, more common in females. Aetiologies of TMJD are multifactorial and can be attributed to both physical and psycho-social factors. Internal derangement of the temporomandibular joint (TMJ) is the most frequent disorder; with anterior disc displacement is the most common form. Wilkes has classified internal derangement into five stages; patients with stage III usually present with limited mouth opening, joint pain and deviation of jaw upon opening to the affected side. MRI is considered the gold standard for diagnosis. Treatment of TMJD include non-surgical and surgical methods. Non-surgical treatment includes instructions, pharmacotherapy, physiotherapy and occlusal splints; while surgical interventions include minimally invasive procedures (arthroscopy and arthrocentesis) and open joint surgery

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Arthroscopy of TMJ was first introduced by Ohnishi in 1975. There are three different levels of TMJ arthroscopy. Level I, single puncture arthroscopy, it allows lysis of adhesions in the upper joint compartment and lavage of the joint space and the inflammatory products. Level II is done by double puncture and it enables to perform maneuvers such as lateral pterygoid myotomy and ablation of the retrodiscal tissue. Operative devices including arthroscopic instruments, Nd-YAG and Holmium laser, and the high-frequency wave system (Coblation) is very useful for tissue coagulation and cutting. Both levels enabled getting joint mobilization and significant pain reduction. Level III (arthroscopic discopexy), it needs customized special instruments.

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Assiut, Egypt, 71111
        • Assiut University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Wilkes stage III patients

Exclusion Criteria:

  • previous TMJ surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TMJ dysfunction
TMJ arthroscopy
Procedure: TMJ arthroscopy
level I and level II TMJ arthroscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
maximum inter-incisal opening
Time Frame: 6 months
change of maximum inter-incisal opening, in mm.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mohamed Gamal Thabet

Investigators

  • Principal Investigator: Mohamed Gamal Thabet, MD, MGThabet

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 13, 2024

Primary Completion (Estimated)

October 13, 2025

Study Completion (Estimated)

October 15, 2025

Study Registration Dates

First Submitted

October 21, 2024

First Submitted That Met QC Criteria

October 25, 2024

First Posted (Actual)

October 28, 2024

Study Record Updates

Last Update Posted (Actual)

October 28, 2024

Last Update Submitted That Met QC Criteria

October 25, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TMJ arthroscopy

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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